Nasal interface device

ABSTRACT

A nasal interface device and a method of use are disclosed. The device includes a facial adaptor configured to be secured to the nose of a user and having two nostril pads having open channels configured to be inserted into nostrils of the use and a piercing/swivel adaptor configured to interact with the facial adaptor through the two nostril prongs. The piercing/swivel adaptor is further configured to be coupled to an airway tube, the airway tube is configured to supply air/gas to the user.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims priority to U.S. patent application Ser.No. 12/383,316, filed Mar. 23, 2009 which claims priority from U.S.Patent Provisional Patent Application No. 61/070,303 to Daly, filed Mar.21, 2008, and entitled “Nasal Interface Device”, and incorporates itsdisclosure herein by reference in its entirety.

The present application also relates to U.S. patent application Ser. No.11/405,948, filed on Apr. 17, 2006, U.S. patent application Ser. No.11/787,854, filed on Apr. 17, 2007, and International Patent ApplicationNo. PCT/US2007/009454, filed on Apr. 17, 2007, the disclosures of whichare incorporated herein by reference in their entireties.

BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates generally to treatment of breathingdisorders. In particular, the present invention relates to a nasalinterface device that is relatively small, lightweight, easy to use, andcan be connectable to a breathing apparatus.

2. Background of the Invention

Sleep-disordered breathing (“SDB”) includes all syndromes that posebreathing difficulties during sleep. These include obstructive sleepapnea (“OSA”), mixed sleep apnea (“MSA”), central sleep apnea (“CSA”),Cheyne-Stokes respiration (“CSR”), and others. Some form of SDB occursin approximately 3-5% of the U.S. population.

Anatomical problems such as obesity or an abnormally narrow upper airwayare known to cause obstructive forms of SDB, in which the airway isvulnerable to collapse as a result of fluid dynamic stresses imposed bybreathing. These stresses produce collapse during sleep, especiallyduring rapid-eye-movement (“REM”) sleep, when there is a reduction inthe tone of muscles holding the airway open. An appropriate interface isrequired in order to deliver continuous positive airway pressure(“CPAP”) therapy, during which air pressure in the range of 4-25 cm H₂Ois delivered from a pressure generator, via delivery hosing, and throughthe interface in order to pressurize the airway so that it will resistsuch collapse. Various types of interfaces are known, including nasalmasks covering and creating a seal with the skin surrounding the nose,oro-nasal masks covering and creating a seal with the skin surroundingthe nose and mouth, and “nasal pillow” devices which directly engage thenares of the nose by inserting soft, expandable elastomer tubes justinside the entrance to the nostrils. Small leaks are acceptable in suchdevices, which in any ease usually incorporate an exhalation orificeproducing a fixed leak in the range of 30-50 liters per minute toprovide bias flow for the pressure generator and to prevent rebreathingof exhaled gases.

Neurological difficulties in controlling levels of blood gases, such ascarbon dioxide (“CO₂”) and oxygen (“O₂”), are increasingly beingrecognized as important contributors to other forms of SDB. This isespecially true of the “central” syndromes, MSA, CSA and CSR, which mayaccount for as much as 20% of all SDB. Changes in the neurologicalsystem that control blood gases often produce cyclic fluctuations inblood gases, and thus, unsteady respiratory patterns that cause arousalsfrom sleep. These changes are accompanied by spikes in blood pressureand release of stress hormones that can cause long-term damage to anumber of organ systems. Additionally, some SDB syndromes involve notonly fluctuations in levels of blood gases, but also abnormal averagelevels of blood gases. For example, low levels of dissolved CO₂ inarterial blood are frequently encountered in CSR, making the bloodalkaline and posing a clinical problem. Therapies directed towards thecentral SDB syndromes may Involve modulation of breathing gases orcontrol of exhalation of carbon dioxide. These therapies are able tostabilize respiration and establish appropriate blood gas levels byrestoring normal control of blood gases. When such therapies are in usesubstantially leak-proof interfaces are required in order to permitcareful control of the gases being exchanged between the therapy devicesand the user. Leaks as small as one liter per minute, which would equateto the amount of flow that would pass through a hole as small as 1millimeter in diameter, may negate the effects of the therapy. Thus,many conventional interface designs currently in use for delivery ofCPAP therapy would not be suitable for use in treatment of the centralSDB syndromes, and a much more secure interface design is needed foroptimum therapy.

Respiratory interfaces typically provide gaseous substance(s) to a userin a variety of applications, including treatment of the abovereferenced illnesses, anesthesiology, and assistance in breathing.

Many respiratory therapies attempt to manage precisely the inhaled,mixed and exhaled gases for a user. This may be achieved through a tightseal between the interface and facial contours of the user. A tight sealmay be necessary not only in order to provide precise control of gasesexchanged with the user, but also to prevent escape of inhalationalagents into ambient air where they may affect clinical personnel. Forexample, when a respiratory interface is utilized in treating complexsleep apnea, a closed system is required to control the amount of carbondioxide that is exhaled by the user.

in the past, a tight seal has usually been achieved through the use ofstraps and harnesses to pull the interface tightly against the user'sface. Since facial geometries vary, the amount of pressure applied tothe skin by the interface will vary from place to place on the face,creating “hot spots” where pressure may be quite high. In someinstances, the pressure may be high enough to prevent effective bloodperfusion at the hot spots, causing long-term skin breakdown and damageto the face of the user. Therefore, it may be desirable to have aninterface that conforms to a users face and puts little or no positivepressure on the user's face while providing a sufficient seal.

The hoses and tubes associated with many respiratory therapies applyvarious torque forces to the interface, making desirable for theinterface to be sufficiently rigid or stiff to provide a stable physicalplatform to resist such forces, and to provide the user with theperception of security and stability of the interface and seal when inuse. In the case of respiratory interfaces that create a seal byengaging the nares of the nose with nasal pillows, it is essential thatinterface provide a geometrically stable platform to hold the nasalpillows securely in relationship to the nose, otherwise there is a riskthat torque forces will cause one or both of the nasal pillows todisengage from the nare, creating a large air leak.

A competing concern to the rigidity of an interface is its ability toconform to user's individual facial features while providing comfort tothe user. Compliance with continuous positive airway pressure therapy isreported to be less than 50% after one year, primarily as a result ofinterface discomfort. The ability of an interface to conform a user'sthee comfortably is generally provided by a cushion. However, thecushion also serves to distribute forces applied to the interface suchas pulling caused by the attached hoses and tubing, thereby limiting thedegree of conformity with the face and the degree of comfort.

Further, conventional CPAP masks an other interface devices are bulky,heavy, and are difficult operate. Thus, there is a need for alight-weight nasal interface device that can provide air-tightconnection to a breathing apparatus and allow flexibility of movement toits user.

SUMMARY OF THE INVENTION

A nasal interface device and a method of use are disclosed. In someembodiments, the device includes a facial adaptor configured to besecured to the nose of a user and incorporating pads configured to besecured inside the nostrils of a user and further configured to extendinto the interior of one or both nostrils of the user (for illustrativepurposes and ease of description only, also referred to as “nostrilpads”). Each nostril pad is configured to be manufactured from a soft,elastomeric material. In some embodiments, the pad is configured toconform to the interior geometry of the user's nostril and tosubstantially follow the typical interior architecture of the nostril,especially the inner curvature of the nostril, wherein the innercircumference of the nostril at approximately 2-3 millimeters inside thenostril is substantially greater than the inner circumference at theopening of the nostril. In some embodiments, the nostril pads furtherinclude pilot holes disposed in each nostril pad. Each pilot hole isconfigured to be pierced using an appropriately-sized tube or a “nostrilprong” by placing the nostril prong through the pilot hole after thenostril pad is inserted into the nostril. Upon insertion into the user'snostril, the nostril prongs provide a breathing passage through whichair could be inhaled and exhaled without excessive resistance by theuser. In some embodiments, the nostril prongs can be configured to becoupled to a piercing/swivel adaptor configured to interact with afacial adaptor via the two nostril prongs. Insertion of the nostrilprongs into the pilot holes in the facial adaptor would expand the softnostril pads, causing them to flare out and form a tight seal with theinner wall of the nostril, thereby “locking” the facial adaptor into thenose and providing an airtight seat due to the larger diameter of theinside of the nostril relative to the opening of the nostril. Thepiercing/swivel adaptor is further configured to be coupled to an airwaytube, the airway tube is configured to supply air/gas to the user.

In some embodiments, the present invention relates to a method ofapplying a nasal interface device to a nose of a user. The methodincludes securing a facial adaptor to the nose of the user, wherein thefacial adaptor includes soft elastomeric nasal pads with pilot holes.The nasal pads are configured to he inserted into the nostrils of theuser The method further includes inserting a piercing/swivel adaptorincorporating tubular nostril prongs through the pilot holes in order tolock the facial adaptor inside the nostrils and to establish an airchannel, and coupling an airway tube to the piercing/swivel adaptor,wherein the airway tube is configured to supply air/gas to the user.

In some embodiments, the present invention relates to a nasal interfacedevice having a facial adaptor configured to be secured to the nose of auser and having a nostril pad configured to be inserted into a nostrilof the user. The nostril pad is configured to substantially conform toan interior geometry of the nostril upon insertion of the pad into thenostril and includes an open channel protruding through the nostril pad.A nostril tube is configured to be placed through the open channel inorder to supply air/gas to the user.

In some embodiments, the present invention relates to a method of usinga nasal interface device for supplying air/gas to a user. The methodincludes securing a facial adaptor to the nose of the user, wherein thefacial adaptor includes a nostril pad configured to be inserted into anostril of the nose of the user, the nostril pad is configured tosubstantially conform to an interior geometry of the nostril uponinsertion of the pad into the nostril and includes an open channelprotruding through the nostril pad. A nostril tube is configured to beplaced through the open channel in order to supply air/gas to the user.

In some embodiments, the present invention relates to a nasal interfacedevice having a facial adaptor configured to he secured to the nose of auser and having two nostril pads configured to he inserted into nostrilsof the user, and a piercing/swivel adaptor configured to interact withthe facial adaptor through the two nostril pads. The piercing/swiveladaptor is further configured to be coupled to an airway tube, theairway tube is configured to supply air/gas to the user.

In some embodiments, the present invention relates to a method of usinga nasal interface device. The method includes securing a facial adaptorto the nose of the user, wherein the facial adaptor includes nostrilpads configured to be inserted into nostrils of the user, inserting apiercing/swivel adaptor into the nostrils of the user through thenostril pads of the facial adaptor, and coupling an airway tube to thepiercing/swivel adaptor, wherein the airway tube is configured to supplyair/gas to the user.

In some embodiments, the present invention relates to a system forcontrolling breathing of a patient. The system includes a nasalinterface device. The device includes a facial adaptor configured to besecured to the nose of a user and having two nostril pads configured tobe inserted into nostrils of the user, a piercing/swivel adaptorconfigured to interact with the facial adaptor through the two nostrilpads. The piercing/swivel adaptor is further configured to be coupled toan airway tube, the airway tube is configured to supply air/gas to theuser.

Further features and advantages of the invention, as well as structureand operation of various embodiments of the invention, are disclosed indetail below will reference to the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is described with reference to the accompanyingdrawings. In the drawings, like reference numbers indicate identical orfunctionally similar element Additionally, the left-most digit(s) of areference number identifies the drawing in which the reference numberfirst appears.

FIG. 1 illustrates an exemplary nasal interface device, according tosome embodiments of the present invention.

FIG. 2 is a side view from beneath the nose of the nasal interfacedevice shown FIG. 1.

FIGS. 3-4 illustrate various views of an exemplary facial adaptor of thenasal interface device shown in FIG. 1 according to some embodiments ofthe present invention.

FIGS. 5-8 illustrate various views of the facial adaptor shown in FIGS.3-4 being applied to the nose of the user.

FIGS. 9 a-e illustrate in exemplary piercing/swivel adaptor of the nasalinterface device show in FIG. 1, according to some embodiments of thepresent invention.

FIGS. 10-11 illustrate various views of the piercing/swivel adaptorshown in FIGS. 9 a-c being applied to the nose of the user.

DETAILED DESCRIPTION OF THE INVENTION

In some embodiments, the present invention relates to a respiratoryinterface device that can be attached to the face of a user (or apatient) order to allow the user to breathe through the device, wherethe device can be coupled to a breathing apparatus providing positiveair pressure to the user.

FIG. 1 illustrates an exemplary nasal interface apparatus 100, accordingto some embodiments of the present invention. The nasal interface device100 includes a facial adaptor 102 and a swivel/piercing element 104. Thenasal interface device 100 is configured to be coupled to a swivel 106.The tubing 106 can be further coupled to a system for controllingbreathing of a patient (not shown in FIG. 1), such as those described inthe co-owned/co-pending U.S. patent application Ser. No. 11/405,948,filed on Apr. 17, 2006, U.S. patent application Ser. No. 11/787,854,filed on Apr. 17, 2007, and International Patent Application No.PCT/US2007/009454, filed on Apr. 17, 2007, the disclosures of which areincorporated herein by reference in their entireties.

FIG. 2 is a side view of the nasal interface apparatus 100 shown inFIG. 1. FIG. 2 further illustrates that the swivel/piercing element 104allows the tubing 106 to rotate as the user moves his/her head the userrolls to the side on his/her bed during sleep). In some embodiments, thetubing 106 is configured to be coupled to the system for controllingbreathing (not shown in FIGS. 1 and 2) that can he discretely disposedabove the user's head or away from sight to sustain an aestheticappearance of the room and prevent formation of the tubing clutteraround the user.

FIGS. 3-4 illustrate exemplary facial adaptor 102, according to someembodiments of the present invention. The facial adaptor 102 isconfigured to be coupled to the user's nose at various locations on thenose, as illustrated in FIGS. 5-8. The facial adaptor 102 includes noseattachment portions 304 and 308. The first portion 304 is configured tobe attached to the bridge of the user's nose. The first portion 304includes a strip 314 and side flaps 306 a and 306 b. The strip 314includes a proximate end 322 and a distal end 324. The side 306 areconfigured to be coupled at or substantially adjacent to the distal end324 of the strip 314. The strip 314 is figured to be bendably coupled tothe second portion 308 of the facial adaptor 102 at the bendableconnection 326.

The side flaps 306 of the strip 314 are configured to bend around theaxis strip 314. The side flaps 306 are configured to have a curvedshape. The width, length, and height of the side flaps 306 areconfigured to accommodate the height of the bridge of the user's nose.The length of the strip 314 can be configured to accommodate length ofbridge the user's nose. Thus, the present invention can be manufacturedin way to accommodate child and adult users having varying facialparameters.

In some embodiments, the strip 314 and the side flaps 306 can beconfigured to include various means of attachment (shown in FIGS. 3-4)to allow further securing of the strip 314 and the flaps 306 to the noseof the use. In some embodiments, the strip 314 and the flaps 306 can beconfigured to form a friction clamp, whereby upon placement of the snip314 and the flaps 306 on the bridge of the nose, the flaps 306 are benttoward the nose in a pinching-type motion, thus, gently squeezing thenose and preventing slippage of the facial adaptor 102 from the nose. Insome embodiments, the flaps 306 can include various materials that canbe configured to retain a certain shape once they are bent into aparticular configuration and/or subject to a certain temperatures. Insome embodiments, the flaps 306 can be configured to include any othermeans for attaching the flaps to the nose of the user, including but notlimited to, adhesives, glue, friction devices, straps, or any othersuitable devices. In some embodiments, the strip 314 is configured to beplaced over the top of the bridge of the user's nose (or over the skincovering cartilage of the septum). The strip 314 is attached to thebridge of the user's nose in a way so that the proximate end 322 of thestrip 314 is configured to coincide with the tip of the user's nose.Such attachment allows bending of the facial adaptor 102 at the bendableconnection 326. Such attachment further allows the user to bend secondportion 308 in a downward direction toward nasal airways of the user.Once the strip 314 is placed on the bridge of the user's nose, the sideflaps 306 are forced in a downward direction toward the skin of the noseand are further attached to the nose as discussed above. As can beunderstood by one having ordinary skill in the art, the facial adaptor102 can be manufactured from materials that can be configured to allowthe adaptor 102 to retain a certain shape upon bending or twisting theadaptor 102 in a particular way.

The second portion 308 is configured to cover a bottom portion of theuser's nose underneath the tip of the nose. In some embodiments, thesecond portion 308 can be shaped substantially similar to the bottomportion of the user's nose. In some embodiments, the second portion 308has a substantially triangular shape. The second portion 308 has asubstantially flat interior surface 332 that is configured to interactwith the bottom portion of the nose. In some embodiments, the interiorsurface 332 is configured to cover the bottom edges of the user'snostrils upon adaptor 102 being installed on the user's nose. In someembodiments, the interior surface 332 can include glue, adhesives,friction-type devices, straps or any other types of mechanisms that areconfigured to further secure the facial adaptor 102 to the nose of theuser. The second portion 308 further includes nostril pads, protrusions,or otherwise extensions (winch will be referred to as “pads” in thefollowing description) 312 a and 312 b. In some embodiments, the nostrilpads 312 are configured to have substantially teardrop shape andprotrude substantially vertically away from the interior surface 332. Insome embodiments, the nostril pads 312 can be configured to protrude atan angle with regard to the interior surface 332. Further, the nostrilpads 312 can be configured to have any desired shape. In someembodiments, the nostril pads 312 can be configured to create asubstantially hermetic fit inside user's nostrils. As such, no air/gascan escape from the nostrils while the user is using the above device.As can be understood by one skilled in the art, the sizes of the nostrilpads 312 can differ in order to accommodate varying size nostrils (e.g.,children and adults). As can be further understood by one skilled in theart, the pads 312 can have any desired shape, including teardrop,cylindrical, oval, or any other suitable shape.

In some embodiments, the nostril pads 312 can be configured to have agreater diameter (or otherwise be larger) at the end distal from theinterior surface 332 than the diameter of the nostril pads at the endproximate to the interior surface 332. This allows for the nostril padsto better conform to the interior geometry of the user's nose, wherebythe diameter of a nostril may be greater at a point distal from theopening of the nostril than the diameter of the nostril at its opening.

In some embodiments, the nostril pads 312 include pilot holes 342 (a,b), respectively, formed along the axis of the nostril pads 312. Thepilot holes 342 create open or pilot channels and allow insertion oftubes or nostril prongs disposed on the swivel/piercing element 104 (asshown and discussed below with regard to FIGS. 9 a-c).

Side flaps 310(a) and 310(b) are coupled to the second portion 308 viabendable connections 344. As illustrated in FIG. 4, side flaps 310 areconfigured to fit immediately adjacent to the sides of the bottom of thenose of the user, e.g., along the side of the nose where the nose meetsthe face. Once the user places the facial adaptor 102 on the nose, theflaps 310 are configured to be bent up from the interior surface 332 ofthe adaptor 102 and be placed on the side of the user's nose in such amanner as to provide a clamping action that further secures adaptor 102to the bottom portion of the nose. In some embodiments, the interiorsurface of side flaps 310 can be configured to include various means ofattachment, including but not limited to, friction-type mechanisms andclamps, adhesives, glues, straps and any other suitable devices thatthat allow side flaps 310 to attach to the side of the nose.

In some embodiments, the facial adaptor 102 can he configured to beformed from a suitable biomedically compatible grade of soft elastomersuch as polyurethane plastic. As can be understood by one skilled in theart, the facial adaptor 102 can be formed from any suitable material.Further, the facial adaptor 102 (with the exception of the nostril pads312) can have a thickness on the order of 3-5 millimeters. In someembodiments, a friction-type mechanism, a glue, a thin-film adhesive, orany other suitable attachment means can be applied to theabove-described parts of the facial adaptor 102. In some embodiments,the attachment means can be configured to create a non-permanentattachment to the skin of the user, thus, allowing the user totemporarily apply the facial adaptor 102 to user's face and remove it asnecessary. Further, the attachment means can be such that same facialadaptor 102 can be removed from the user's face and then re-applied,e.g., the facial adaptor can use a repositionable attachment means thatallows the user to remove and reapply the adaptor. In some embodiments,the facial adaptor 102 can be a single or as multi-use device. In someexemplary embodiments, the weight of the facial adaptor 102 can be onorder of 2 to 7 grams (“g”).

The nostril pads 312 can be manufactured from a soft elastomericmaterial, such as medical grade polyurethane or any other suitablematerial. The elastomeric material can be configured to have a varyinghardness coefficient that determines how flexible/hard this material canbe. The hardness coefficient can be measured using a Shore-A scalehaving values between A 00, corresponding to the softest material, and A100, corresponding to the hardest material. As can be understood by oneskilled in the art, the nostril pads 312 can have a hardness coefficientin the range of approximately A 00 to approximately A 60. In someembodiments, the nostril pads 312 can be injection molded and attached(by any methods, including gluing, stapling, welding, thermo-gluing, orany other methods) to the interior surface 312 of the second portion308. In some embodiments, the entire facial adaptor 102 can bemanufactured from a single material, such as polyethylene, polyurethane,polyester, and an other plastic polymers.

The nostril pads 312 are configured to be disposed substantially in thecenter of the second portion 308 of the facial adaptor 102 and furthermatch the location of user's nostrils so that upon insertion of thenostril pads 312 into the user's nostrils, the nostril pads 312 arecomfortably disposed inside user's nostrils. In some embodiments, thenostril pads 312 can be disposed at an angle with regard to each other,as illustrated in FIGS. 3-4. With just the nostril pads 312. (i.e.,without the breathing tubes or nostril prongs) being inserted into theuser's nostrils, the user may be able to breathe through the nose.However, upon insertion, of the breathing tubes, the nostril pads 312expand inside the nostrils to provide a hermetic seal and, as statedabove, do not allow leaking of air/gas between the interior walls of thenostrils and the pads.

In some embodiments, the nostril pads 312 can be used independently ofthe rest of adaptor 102 and configured to be individually inserted bythe user into each nostril. In some embodiments, the nostril pads 312can include a connector that connects the two pads 312. The connectorallows the pads to be inserted into both nostrils simultaneously.

In order to put the facial adaptor 102 on the face, the user may performthe following steps. As discussed below, these steps may not necessarilybe performed in the order that they are described. As can be understoodby one skilled in the art, the steps can be performed in any order. Insome embodiments, the user may first align the proximate end 322 of thefirst portion 304 with the tip of the user's nose and then apply thestrip 314 along with wingtips 306 to the bridge and sides of the user'snose. Upon applying the strip 314 to the bridge of the user's nose, thewingtips 306 are bent in a downward direction and are applied to thesides of the user's nose. Then, the second portion 308 is bent in adownward direction toward the user's nostrils in order to cover thenose's airways. The nostril pads 312 are inserted into the nostrils. Theside flaps 310 are then bent in an upward direction along the sloe ofthe user's nose. FIGS. 5-8 illustrate the facial adaptor 102 beingplaced over the user's nose.

In some embodiments, the facial adaptor 102 can be packaged by amanufacturer in a single-use sealed tray. The user would remove theadaptor 102 from the tray, (in embodiments using adhesives, the useralso removes the adhesive liner coveting the adhesive on the facialadaptor 102), then insert the nostril pads 312 into the user's nostrils,and then apply other portions of the facial adaptor 102 to the user'sface (i.e., the first portion 304 is applied to the bridge of the user'snose and the side flaps 310 to the side of the user's nose).

In some embodiments, the strip 314 of the first portion 304 can bestiffened with laminated elastomer/PET structures. The bendableconnections 326 and 344 as well as those. between wingtips 306 and thestrip 314 can be configured to be molded-in ridges that allow bending ofthe appropriate components of the facial adaptor 102. Further, thewingtips 306 as well as side flaps 310 can be configured to provide,some squeezing three to the user's nose, when the facial adaptor 102 isapplied to the nose, in order to further secure the adaptor 102 to thenose.

FIGS. 9 a-c illustrate an exemplary swivel/piercing element 104,according to some embodiments of the present invention. Theswivel/piercing element 104 includes a housing 902, nostril prongs ortubes 906(a, b), a connector tube 904, and a swivel adaptor 922. Thehousing 902 further includes an interior surface 912 and an exteriorsurface 914. The interior surface 912 is configured to interact with thefacial adaptor 102 (not shown in FIGS. 9 a-c). The exterior surface 914is facing away from the user's nostrils. In some embodiments, the shapeand size of the housing 902 is configured to conform to the shape andsize of the second portion 308 of the facial adaptor 102 (now shown inFIGS. 9 a-e) and can have a substantially triangular shape, asillustrated in FIGS. 9 b and 9 c. As can be understood by one skilled inthe art, the element 104 can have any other desired shape and size.

The nostril tubes 906 are configured to protrude away from the interiorsurface 912. The tubes 906 are configured to be inserted into theopenings or pilot holes 342 created in the nostril pads 312 (not shownin FIGS. 9 a-e). Upon insertion of the nostril tubes 906, the tubes 906are configured to push the elastomeric material of the nostril pads 312away from the outer surface of the tubes 906 and toward the interiorsurfaces of the user's nostrils. By pushing the elastomeric material insuch manner, the tubes 906 along with the nostril pads 312 areconfigured to create an air-tight seal in the nostrils, so that the onlyair/gas that is able to travel into the user's nose would go through thetubes 906 of element 104 and no air/gas can leak between the nostrilsand the nostril pads 312.

The connector tube 904 is configured to protrude away from the exteriorsurface 914 of the housing 902. The tube 904 is configured to connect tothe airway tube 106 not shown in FIGS, 9 a-c, but is shown in FIG. 1).To allow such connection, the tube 904 includes a swivel adaptor 922.The swivel adaptor 922 allows the airway tube 106 to rotate in anydesired direction, as indicated by directional arrows A and B. Suchrotation provides flexibility to the user, for example, when the user isrolling around in bed, walking around, or any performing any otheractivities.

The housing 902 and the tubes 906 and 904 are further configured tocontain interior connector tubing 910 and 916 that connects tubes 906and 904. Such interior connector tubing 910 and 916 provides airwaysfrom the user's nostrils through the tips 908, into the tubes 906,through the housing 902, into the tube 904, and then into the airwaytube 106 (not shown in FIGS. 9 a-c). When the nasal interface apparatus100 is fully connected, as shown in FIGS. 1 and 2, the air/gas cantravel to/from user's nostrils and into the airway tube 106.Alternatively, the housing 902 can be substantially hollow, providing aninternal connection between the tubes 906 and 904. In some embodiments,the airway tube 106 can connected to a CPAP machine, as disclosed inco-owned/co-pending U.S. patent application Ser. No. 11/405,948, filedon Apr. 17, 2006, U.S. patent application Ser. No. 11/787,854, filed onApr. 17, 2007, and International Patent Application No,PCT/US2007/009454, filed on Apr. 17, 2007, the disclosures of which areincorporated herein by reference in their entireties.

Referring to FIGS. 9 a-c, once the user has attached the facial adaptor102 to his/her nose, the element 104 is inserted, using its tubes 906,through the openings 342 (not shown in FIGS. 9 a-c). FIGS. 10-11illustrate such element 104 being coupled to the facial adaptor 102. Theairway tube 106 can then be coupled to the swivel adaptor 922, asillustrated in FIGS. 1 and 2. As can be understood by one skilled in theart, this assembly can be disconnected at will. In some embodiments, theelement 104 can he manufactured from a light, semi-rigid Teflonmaterial. As can be understood by one skilled in the art, the element104 can be manufactured from any polyester, polyethylene, or any otherpolymer materials. The element 104 can be reusable or disposable. Theswivel adaptor 922 can be any conventional swivel mechanism that allowsrotation of the airway tube 106 once it is connected to the swiveladaptor 922.

In some embodiments, the thickness of the housing 902 can be on theorder of 6-10 mm. Further, the length of the tubes 906 and 908 can be onthe order of between approximately 4 mm to approximately 7 mm.

In some embodiments, each nostril pad 312 can be separately insertedinto each respective nostril of the user, where nostril pads 312 are notattached to any external supporting devices, such as adaptor 102. Insome embodiments, the nostril pads 312 can be configured to be coupledto a friction damp or any other fixation device, which can be similar tothe pads 306 being coupled to the first portion 304, that is configuredto further secure the nostril pads 312 to the nose of the user.Additionally, in some embodiments, each one of the nostril prongs 906can be configured to be separately inserted through the pilot holes 342of the nostril pads without being coupled to the housing 902, i.e., eachprong 906 can be coupled to a tube, which is further connected to anairway device. The prongs 906 are configured to create a lockingarrangement inside the user's nostrils once the prongs 906 are insertedthrough the pilot holes 342.

In some embodiments, the present invention can he used in connectionwith a system for controlling breathing of a patient. The exemplarysystem includes the facial adaptor discussed above coupled to an airwaydevice for supplying air/gas to the patient via an airway tube. Suchsystem can be employed anywhere, including user's home, hospital,clinic, or any other facility. The system and/or the nasal interfacedevice can he operated by the user himself/herself or a medicalprofessional (e.g., doctor, nurse, etc).

Example embodiments of the methods, circuits, and components of thepresent invention have been described herein. As noted elsewhere, theseexample embodiments have been described for illustrative purposes only,and are not limiting. Other embodiments are possible and are covered bythe invention. Such embodiments will be apparent to persons skilled inthe relevant art(s) based on the teachings contained herein. Thus, thebreadth and scope of the present invention should not be limited by anyof the above-described exemplary embodiments, but should be defined onlyin accordance with the following claims and their equivalents.

1. A method of using a nasal interface device for supplying air/gas to auser, comprising: securing a facial adaptor to the nose of the user,wherein the facial adaptor includes a nostril pad configured to beinserted into a nostril of the nose of the user, said nostril pad isconfigured to substantially conform to an interior geometry of thenostril upon insertion of the pad into the nostril and includes an openchannel protruding through the nostril pad; wherein a nostril tube isconfigured to be placed through said open channel in order to supplyair/gas to the user.
 2. The method according to claim 1, furthercomprising: inserting a piercing/swivel adaptor into the nostrils of theuser through the nostril pads of the facial adaptor; and coupling anairway tube to the piercing/swivel adaptor, wherein the airway tube isconfigured to supply air/gas to the user.
 3. The method according toclaim 2, further comprising: attaching the facial adaptor to the nose ofthe user using a friction clamp, wherein the friction clamp isconfigured to be coupled to at least one or both of a bridge of the noseand/or one or both sides of the nose.
 4. The method according to claim3, wherein the facial adaptor comprises: a first portion configured tobe secured to the bridge of the user's nose; a second portion coupled tothe first portion via a bendable connection and configured to cover thenostrils of the user's nose; and a third portion coupled to the secondportion via another bendable connection and configured to be secured byfriction on the sides of the user's nose, the second portion isconfigured to be coupled to said nostril pad.
 5. The method according toclaim 2, wherein the piercing/swivel adaptor includes: a housing havingan interior surface and an exterior surface, the nostril tube configuredto protrude away from the interior surface of the housing; a connectortube configured to protrude away from the exterior surface of thehousing, the nostril tube is configured to be located on an oppositeside of the housing as the connector tube; the connector tube furtherincludes a swivel element configured to allow connection of the airwaytube; the nostril tube and the connector tubes are configured to beconnected to each other via an airway passage disposed inside thehousing of the piercing/swivel adaptor.
 6. The method according to claim5, further comprising: inserting the nostril tube into the open channelof the nostril pad.
 7. The method according to claim 6, wherein uponinsertion of the nostril tubes into the open channels, thepiercing/swivel adaptor is configured to create an airway passagebetween the nose of the user and the airway tube when the airway tube iscoupled to the swivel element of the piercing/swivel adaptor.
 8. Themethod according to claim 7, wherein the swivel element allows rotationof the airway tube when the airway tube is coupled to the swivelelement.
 9. The method according to claim 4, wherein the facial adaptoris manufactured from any biocompatible elastomeric material having aShore A hardness rating in range of approximately Shore A 00 toapproximately Shore A
 60. 10. The method according to claim 1, whereinthe nostril pads are manufactured from an elastomeric material.
 11. Themethod according to claim 3, wherein the facial adaptor furthercomprises two nostril pads, wherein each nostril pad includes arespective open channel.
 12. The method according to claim 11, whereinthe piercing/swivel adaptor further comprises two nostril tubesconfigured to be inserted into each respective open channel in thenostril pads.
 13. A nasal interface device, comprising: a facial adaptorconfigured to be secured to the nose of a user and having two nostrilpads configured to be inserted into nostrils of the user; apiercing/swivel adaptor configured to interact with said facial adaptorthrough said two nostril pads; wherein said piercing/swivel adaptor isfurther configured to be coupled to an airway tube, said airway tube isconfigured to supply air/gas to the user.
 14. A method of using a nasalinterface device, comprising: securing a facial adaptor to the nose ofthe user, wherein the facial adaptor includes nostril pads configured tobe inserted into nostrils of the user; inserting a piercing/swiveladaptor into the nostrils of the user through the nostril pads of thefacial adaptor; and coupling an airway tube to the piercing/swiveladaptor, wherein the airway tube is configured to supply air/gas to theuser.
 15. A system for controlling breathing of a patient, comprising: anasal interface device, having a facial adaptor configured to be securedto the nose of a user and having two nostril pads configured to beinserted into nostrils of the user; a piercing/swivel adaptor configuredto interact with said facial adaptor through said two nostril pads;wherein said piercing/swivel adaptor is further configured to be coupledto an airway tube, said airway tube is configured to supply air/gas tothe user.